The Atlantic Center for Research serves as a central point of contact for sponsors and investigators of clinical trials who are affiliated with our hospitals, as well as attending physicians interested in conducting a clinical trial and physicians looking to refer a patient to a research study.
We facilitate and coordinate all clinical research activities to expedite study initiation and to ensure strict compliance with the highest standards of research conduct.
The Atlantic Center for Research offers:
- Centralized clinical trial management
- Extensive experience in pharmaceutical and medical device trials
- Diverse inpatient and outpatient populations
- Expert oversight of clinical trial conduct
- Professional, experienced clinical research coordinators
- Physician investigators in all specialties
- Centralized IRB review
- Subject recruitment and screening
- Strict compliance with FDA and good clinical practice standards
- Complete financial and administrative management
- Prompt review and execution of contracts
- Dedicated, experienced research pharmacists
Atlantic Health System employees can access SOPs and important documentation on the employee intranet. Under "Departments," select "Atlantic Center for Research."
Grants, Contracts, and Budgeting
The Atlantic Center for Research provides grants and contracts services to Atlantic Health System-affiliated physicians and to non-affiliated physicians who wish to seek our services on a case-by-case basis.
The grants, contracts and budgeting team can assist with the following actions:
- Working with prospective grantees to plan proposals and submit grant applications
- Developing grant and clinical research budgets and finalizing contracts
- Managing research study pre-award and post-award finances
Institutional Review Board (IRB)
At Atlantic Health System, participating in clinical trials allows patients to take advantage of innovative treatments and procedures as we work together to advance the future of medicine.
Below are frequently asked questions and requested information concerning the roles and responsibilities of the IRB.
How do we minimize risk?
The risk to human research subjects is minimized through a standardized review process. In accord with federal regulations, all clinical trials in the U.S. must be approved by an independent review group, called the Institutional Review Board, or IRB. IRB members include clinicians and individuals from the community who have no direct interest or participation in the study.
What are the responsibilities of the IRB?
The IRB is responsible for evaluating the ethics and scientific value of a study as well as for protecting subjects’ rights and welfare. It has sole authority to approve, require modifications in, or disapprove of any research activity. The IRB review process ensures that the proposed study has satisfactorily answered such important questions as:
- Is the research scientifically sound?
- What are the risks to human subjects, and have the risks been minimized?
- How will subjects benefit from the research?
- Have subjects been selected in a fair and equitable manner?
- Will the data be adequately monitored?
- What will the researcher do with the subjects’ information?
- Will the subjects’ privacy and confidentiality be maintained?
- Has the study team informed potential subjects of all details of the study?
- Have the potential subjects willingly consented to be part of the study, and do they have the capacity to consent? (Some situations require additional safeguards, such as when subjects are children, are handicapped, or when there are language barriers.)
What are the responsibilities of the study team?
Investigators, coordinators, and assistants share in the obligation to uphold the ethical, legal, and regulatory requirements for human subject protection. The principal investigator (PI) bears direct personal responsibility for protecting every research subject enrolled in his or her study. The PI is also responsible for ensuring that all members of the study team uphold their ethical and regulatory responsibilities for human subject protection.
What are the responsibilities of the organization?
The organization must provide the commitment, leadership, infrastructure, continuing education and compliance oversight necessary to protect human subjects. It must also provide written assurance to the appropriate federal agencies that the organization conducts research in accord with accepted ethical standards and specific regulatory requirements (the “Common Rule”). At Atlantic Health System, the IRB is staffed by dedicated professionals who monitor some 400 clinical trials. Atlantic Health System requires that all investigators, study coordinators and research staff complete an IRB-approved education component in human subject protection as well as periodic continuing education programs. Additionally, all research personnel must complete a Federal Funds Compliance Education module. No investigator conducting research under Atlantic Health System auspices will receive IRB approval for a new protocol or for an extension without proof that the educational requirements have been fulfilled.
To what types of research does IRB oversight apply?
Protection of participants extends to any experiment that involves a drug, device or biologic test item. This encompasses a wide range of research, including tissue specimens, medical records, genetic materials, behavioral and/or biomedical assessments, and treatments. Some examples:
- Procedures or treatments that are innovative when compared to the accepted standard
- Research on residual diagnostic specimens, including those obtained for routine patient care that would be discarded if not used for research
- Research involving private information that can be readily identified with an individual (such as retrospective chart reviews), even if the information was not specifically collected for the study in question
- Surveys and questionnaires where identifiers can link the responses to individuals or that contain questions of a sensitive or questionable nature
- Research on bodily materials such as cells, blood, urine, tissues, organs, hair or nail clippings, even if the researcher did not collect these materials
- The care of patients or the assignment of healthy volunteers to any intervention that is altered for research purposes in any way
- Research conducted in collaboration with other hospitals, universities, or research centers, even if the outside institution’s IRB has already approved the study
All human-subject research conducted at Atlantic Health System facilities or by anyone as an agent of Atlantic Health System must be reviewed and approved by the IRB prior to initiation of the study.
Are some studies exempt from IRB approval?
Some research involving human subjects may be exempt from regulations requiring IRB approval due to the minimal risk of the study and a lack of participant identifiers. However, the study still must be submitted for review to the IRB, which makes the final determination on whether a study is exempt. Following are some examples of minimal-risk research that the IRB may designate as exempt:
- Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified.
- Research conducted in commonly accepted educational settings involving normal educational practices, such as research on education instructional strategies.
- Research involving survey procedures, interview procedures, the use of educational tests, or observation of public behavior, as long as the information obtained is recorded in such a manner that subjects cannot be identified.
Who oversees Atlantic Health System’s IRB, and where can I get more information?
The Atlantic Health System IRB is led by Roger Kurlan, MD, director of the Movement Disorders Program at Atlantic Neuroscience Institute. The vice chair is John Allegra, MD, emergency medicine, who shares in IRB oversight responsibilities.
The IRB Manager and IRB Coordinator direct the IRB’s day-to-day functions and can help you understand the regulatory requirements governing human subject research.
Atlantic Health System investigators can seek statistical guidance for their research projects and grant proposals by contacting the biostatistics manager at the Atlantic Center for Research. In seeking statistical guidance for their research activities and study protocols, Atlantic Health System investigators are requested to review the following six steps:
Step 1: Research Design
Atlantic Health System investigators can seek help regarding the appropriate research design (type of data to be collected, sampling, randomization, number of subjects needed, etc.) for their research initiatives and grant proposals. No statistical analyses will be performed at this stage.
Step 2: Review of IRB Guidelines
All Atlantic Health System investigators are requested to review guidelines for study protocols in regards to IRB approval. In this regard, research activities are classified into different categories depending on the nature of these activities.
Step 3: Analysis Plan
Atlantic Health System investigators may seek help regarding the appropriate statistical methodology for their research initiatives and grant proposals. Help is provided in the preparation of analysis plans which may include descriptive statistical methods, and/or basic/advanced statistical modeling techniques or both.
Step 4: Data Collection
Data may be collected and saved electronically using appropriate software (e.g., Microsoft Excel, Microsoft Access).
Step 5: Statistical Analysis and Interpretations
Atlantic Health System investigators may seek help regarding the statistical analyses for their data collected in step 4. Interpretations of the results and conclusions from the analyses can be discussed as needed.
Step 6: Presentations and Publications
Atlantic Health System investigators may seek help with the dissemination of the data they have collected through preparation of technical reports, presentations, or manuscripts for submission to local or international journals.
Investigational Drug Service
The Investigational Drug Service (IDS) supports all clinical drug-related research conducted by investigators at Atlantic Health System. The IDS provides the support needed to assure safe and efficient conduct of clinical drug trials including compliance with federal, state, and The Joint Commission on requirements regarding investigational drugs.
At each Atlantic Health System institution, all investigational drugs are stored within a specially locked area to limit access by non-authorized personnel. The IDS maintains separate IDS refrigerators and freezers. Facilities are available for all extemporaneous compounding of oral, topical and parenteral formulations. The IDS is able to dispense investigational medications to both inpatients and outpatients. IDS policies and operation procedures are maintained by the manager of Investigational Drug Services. The IDS is open for inspection by all investigators and sponsors. Inspections must be scheduled through the IDS coordinator or manager.
Services Provided by the IDS
The IDS is available for all clinical investigations approved by the Atlantic Health System Institutional Review Board:
- Development of educational materials and training for patients and staff
- Drug information services and literature search related to investigational studies
- Assistance with protocol development
- Blinding methodologies
- Preparation of oral, rectal, topical and parenteral dosage forms and matching placebo
- Limited access and security of study drugs
- Appropriate storage according to FDA guidelines
- Maintenance and control of investigational drug inventories
- Performance of randomization services such as IVRS for multicenter investigations
- Daily access to randomize, enroll and dispense study agents to consented subjects
- Maintenance of Drug Accountability Record Forms (DARF) and all study-related files
- Collection of all patient drug returns and reconciliation
- Inventory control and return of all used and unused study drug to the sponsors
- Participation in final close-out of study protocols with the sponsors by providing copies of all drug disposition and inventory control records
- Drug destruction policies in place to destroy expired or used drug on site
- Participation in FDA, NCI, NIH and pharmaceutical sponsor audits
- Archives of all closed clinical study records for up to 15 years after termination
- Computerized randomization schemes
- Special compounding of specially formulated active drug or placebo capsules, suspensions or dosage forms commercially unavailable
- Preparation of blinded encapsulated study drug
- Assistance with pre-printed physician order forms
Initiating an Investigational Drug Study
The IDS requests a copy of the Sponsor’s Protocol and Investigator’s Drug Brochure. The research pharmacist will review the protocol and meet with sponsor representatives, the principal investigator, study coordinator and other study personnel to assess the potential IDS requirements. An IDS budget will be developed for the investigator to adequately plan for all necessary drug-related costs.